公开(公告)号：US12121435B2

公开(公告)日：2024-10-22

申请号：US17851328

申请日：2022-06-28

Applicant: Edwards Lifesciences Corporation

Inventor： Noam Nir ,  Elena Sherman

IPC: A61F2/24 ,  B29C65/00 ,  B29C65/62 ,  B29L31/00

CPC classification number: A61F2/2415 ,  A61F2/2418 ,  B29C65/62 ,  B29C66/1142 ,  A61F2220/0075 ,  A61F2240/001 ,  B29L2031/7534

Abstract: Assembly methods for installing a leaflet assembly to an expandable frame of a prosthetic heart valve are described. The leaflet assembly comprises a plurality of leaflets coupled together at adjacent tabs, which form respective commissure tab assemblies. The commissure tab assemblies are inserted into corresponding windows of support members of the expandable frame. One or more wedge members are inserted into the commissure tab assembly, e.g., between the adjacent tabs or with the adjacent tabs therebetween, to restrain radial motion of the commissure tab assembly with respect to the window. The window can be a closed window, and the wedge member insertion can be after the commissure tab assembly is inserted into the window. Alternatively, the window can be an open window or channel, and the wedge member insertion can be before the commissure tab assembly is installed in the window.

公开(公告)号：US20240285401A1

公开(公告)日：2024-08-29

申请号：US18658051

申请日：2024-05-08

Applicant: EDWARDS LIFESCIENCES CORPORATION

Inventor： Tamir S. Levi ,  Elena Sherman ,  Melissa Fusari ,  Nikolai Gurovich

IPC: A61F2/24

CPC classification number: A61F2/2418 ,  A61F2/2412 ,  A61F2/2433 ,  A61F2210/0057 ,  A61F2220/005 ,  A61F2220/0075 ,  A61F2250/0004 ,  A61F2250/0039 ,  A61F2250/006 ,  A61F2250/0097 ,  A61F2250/0098

Abstract: A prosthetic heart valve including an annular frame and one or more detachable outer skirts and methods associated therewith. The frame has one or more outer skirts releasbly attached to an exterior surface of the frame. In some examples, an outer skirt is attached to the frame via at least one retaining suture formed by stitches looped around a pull suture and struts of the frame. Portions of the outer skirt are captured between the pull suture and the exterior surface of the frame along a suture line. Removal of the pull suture from the suture line enables the outer skirt and frame to separate as the stitches are pulled through openings in the outer skirt. In some examples, outer skirts can be releasably attached to the frame via bioresorbable couplers. Removability of the outer skirts can facilitate improvements in implant and explant procedures of the prosthetic valves.

公开(公告)号：US20240207046A1

公开(公告)日：2024-06-27

申请号：US18522551

申请日：2023-11-29

Applicant: EDWARDS LIFESCIENCES CORPORATION

Inventor： Nikolai Gurovich ,  Michael Bukin ,  Anatoly Dvorsky ,  Eran Grosu ,  Noam Nir ,  Joseph Mordechai Leichner ,  Elena Sherman ,  Guillermo W. Moratorio

IPC: A61F2/24

CPC classification number: A61F2/2418 ,  A61F2220/0008 ,  A61F2220/0025

Abstract: A prosthetic heart valve comprises a radially expandable frame comprising an outflow end and an inflow end, and a plurality of valve leaflets disposed within and coupled to the frame. Each leaflet comprises a main body having an outflow edge portion and an inflow edge portion, wherein the leaflets are configured to move between an open state and a closed state in which the outflow edge portions coapt with each other and block the flow of blood through the frame from the outlet end to the inlet end, wherein the inflow edge portion of each leaflet includes a movable portion that can move radially inwardly when the leaflets move to the closed state to assist with the coaptation of the outflow edge portions of the leaflets and radially outwardly when the leaflets move to the open state.

公开(公告)号：US20240180696A1

公开(公告)日：2024-06-06

申请号：US18402589

申请日：2024-01-02

Applicant: EDWARDS LIFESCIENCES CORPORATION

Inventor： Michael Bukin ,  Nikolai Gurovich ,  Elena Sherman ,  Anatoly Dvorsky ,  Eran Grosu

IPC: A61F2/24

CPC classification number: A61F2/2418 ,  A61F2/243 ,  A61F2/2436

Abstract: A prosthetic valve includes an annular frame and a valvular structure mounted within the annular frame. The valvular structure comprises a plurality of leaflets defining a plurality of commissures coupled to the annular frame. Each leaflet includes a leaflet free edge that is offset in a downstream direction from the commissures by side edges that are not attached to the frame. A material portion of the leaflet disposed between the side edges contributes a material slack that extends a radial reach of the leaflet free edge for coaptation. The prosthetic valve can be releasably coupled to a delivery device to form a delivery apparatus. The prosthetic valve can be delivered to a selected implantation site by the delivery apparatus and released at the implantation site by a handle of the delivery device.

公开(公告)号：US20240156594A1

公开(公告)日：2024-05-16

申请号：US18419840

申请日：2024-01-23

Applicant: EDWARDS LIFESCIENCES CORPORATION

Inventor： Tomer Saar ,  Michael Bukin ,  Elena Sherman ,  Alexander Barash ,  Yana Mayatskaya

IPC: A61F2/24

CPC classification number: A61F2/2418 ,  A61F2/2412 ,  A61F2210/0014 ,  A61F2220/0075

Abstract: A prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration can include an annular frame including a plurality of angled strut members, a plurality of leaflets disposed within the frame and secured to the frame, a valve component sutured to a leaflet of the plurality of leaflets and extending along an edge portion of the leaflet adjacent at least one strut member of the plurality of strut members, and a suture threaded around the valve component and extending generally in a direction along a longitudinal axis of the at least one strut member to secure the valve component and the leaflet to the at least one strut member.

公开(公告)号：US20230270541A1

公开(公告)日：2023-08-31

申请号：US18195288

申请日：2023-05-09

Applicant: EDWARDS LIFESCIENCES CORPORATION

Inventor： Tamir S. Levi ,  Shahram Zamani ,  Michael Bukin ,  Ziv Yohanan ,  Noam Nir ,  Tyler Dale O'Dell ,  Elena Sherman

IPC: A61F2/24

CPC classification number: A61F2/2415 ,  A61F2/2418 ,  A61F2220/0075

Abstract: A method of assembling a valvular structure can include folding an upper tab of a first leaflet onto a lower tab of the first leaflet, disposing a first end of a reinforcing member on the upper tab, disposing a commissure member adjacent the lower tab, and coupling the first end of the reinforcing member, the tabs of the first leaflet, and the commissure member to one another. The method can further include folding an upper tab of a second leaflet onto a lower tab of the second leaflet, disposing the second leaflet adjacent the first leaflet such that the commissure member is positioned between the lower tabs, disposing a second end of the reinforcing member on the upper tab of the second leaflet, and coupling the reinforcing member, the upper and lower tabs of the second leaflet, and the commissure member to one another to form a commissure.

公开(公告)号：US20230190459A1

公开(公告)日：2023-06-22

申请号：US18108259

申请日：2023-02-10

Applicant: EDWARDS LIFESCIENCES CORPORATION

Inventor： Noam Nir ,  Tamir S. Levi ,  Ziv Yohanan ,  Michael Bukin ,  Elena Sherman ,  Yana Mayatskaya

IPC: A61F2/24

CPC classification number: A61F2/2418 ,  A61F2/243 ,  A61F2220/0075

Abstract: A prosthetic valve includes a radially expandable and compressible annular frame and a valvular structure. The frame includes a first strut and an adjacent second strut that overlap at a pivot joint. Radial expansion or compression of the frame causes the first strut to pivot relative to the second strut at the pivot joint. The valvular structure includes first and second leaflets attached to the first and second struts with a suture. The first and second struts define four strut segments connected by the pivot joint. The suture comprises three interconnected locking knots that are respectively attached to three of the four strut segments.

公开(公告)号：US11628062B2

公开(公告)日：2023-04-18

申请号：US17707127

申请日：2022-03-29

Applicant: Edwards Lifesciences Corporation

Inventor： Tamir S. Levi ,  Son V. Nguyen ,  Netanel Benichou ,  David Maimon ,  Ziv Yohanan ,  Nikolai Gurovich ,  Bella Felsen ,  Larisa Dadonkina ,  Ron Sharoni ,  Elena Sherman

IPC: A61F2/24

Abstract: Embodiments of a radially collapsible and expandable prosthetic heart valve are disclosed. A valve frame can have a tapered profile when mounted on a delivery shaft, with an inflow end portion having a smaller diameter than an outflow end portion. The valve can comprise generally V-shaped leaflets, reducing material within the inflow end of the frame. An outer skirt can be secured to the outside of the inflow end portion of the frame, the outer skirt having longitudinal slack when the valve is expanded and lying flat against the frame when the valve is collapsed. A diagonally woven inner skirt can elongate axially with the frame. Side tabs of adjacent leaflets can extend through and be secured to window frame portions of the frame to form commissures. The window frame portions can be depressed radially inward relative to surrounding frame portions when the valve is crimped onto a delivery shaft.

公开(公告)号：US20220323209A1

公开(公告)日：2022-10-13

申请号：US17851232

申请日：2022-06-28

Applicant: Edwards Lifesciences Corporation

Inventor： Noam Nir ,  Michael Bukin ,  Elena Sherman

IPC: A61F2/24 ,  B29C65/62

Abstract: An assembly and associated method for a commissure of a prosthetic heart valve is disclosed. As one example, a method includes forming each of a plurality of commissures with a plurality of leaflets by pairing a first commissure tab of a first leaflet with an adjacent, second commissure tab of a second leaflet, folding a support strip over an inner reinforcing element, positioning the folded support strip between the first and second commissure tabs, and attaching first and second outer reinforcing elements to the first and second commissure tabs, respectively, via stitching, the stitching extending over at least a portion of the first reinforcing element opposite a fold region of the support strip, and, for each commissure, securing end portions of the support strip to a respective support portion of a frame of the prosthetic heart valve.

公开(公告)号：US20220241071A1

公开(公告)日：2022-08-04

申请号：US17659577

申请日：2022-04-18

Applicant: Edwards Lifesciences Corporation

Inventor： Nikolay Gurovich ,  Michael Bukin ,  Elena Sherman ,  Tamir S. Levi ,  Ziv Yohanan ,  Gil Senesh ,  Dikla Kersh ,  Alexey Tsypenyuk ,  Waina Michelle Chu ,  Alexander Barash

IPC: A61F2/24

Abstract: A system can include a delivery catheter comprising a balloon and an implantable prosthetic heart valve. The prosthetic valve can have a plastically expandable and compressible unitary frame comprising first, second, and third rows of angled struts that define two circumferentially extending rows of diamond-shaped cells that extend continuously around the frame, and a valvular structure comprising a plurality of leaflets. A cusp edge portion of each leaflet is connected to the frame by a skirt that is connected to and disposed between the frame and the cusp edge portions of the leaflets, the skirt being connected to consecutive struts in the first, second, and third rows of struts with sutures. The compressed prosthetic heart valve can be mounted around the balloon and radially expanded to the expanded configuration with the balloon inside a patient's body.